drugset / Trial / NCT05607615

A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease

NCT05607615 ↗

Phase 2 Unknown 90 enrolled Cyclo Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Approximately 90 patients, aged 50 to 80 years, with a diagnosis of early Alzheimer's disease will take part in this research study. This study will be conducted in the US. There will be 3 treatment groups: 2 Active doses and 1 group will receive placebo completely by chance. Patients, caregiver, Sponsor, nor study staff will know which treatment is assigned. There are 3 periods in this study: Screening to confirm suitability, Treatment to receive study medication, and Follow-up to check overall health post-participation

Timeline

Start
2022-09-23
Primary completion
2024-03-31
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 2-hydroxypropyl-beta-cyclodextrin Unknown 500 mg/kg Intravenous
Subject 2-hydroxypropyl-beta-cyclodextrin Unknown 1000 mg/kg Intravenous

Indications